FDA clearances

510(k) for ABM Respiratory Care's BiWaze Cough, Life Spine's Sterrable Plateau Ti System

ABM Respiratory Care's BiWaze Cough therapy system
ABM Respiratory Care's BiWaze Cough therapy system
ABM Respiratory Care

Elizabeth Engler Modic, Editorial Director - Manufacturing Group

Published June 01, 2020
ABM Respiratory Care received 510(k) clearance to market its small, lightweight BiWaze Cough therapy system, which helps remove secretions for people unable to cough or clear secretions effectively due to reduced peak cough flow resulting from high spinal cord injury, neuromuscular deficits, or severe fatigue associated with intrinsic lung disease. It provides a non-invasive solution to clear secretions from the upper airways compared to invasive suctioning. BiWaze Cough also provides high frequency oscillations to break up thick secretions and help remove them from the lungs.
Life Spine received 510(k)clearance from the U.S. Food & Drug Administration (FDA) to market the Steerable Plateau Ti system, available in 28mm and 32mm lengths and 9mm to 14mm heights in 1mm increments. The system also features Life Spine’s Osseo-Loc Surface architecture of 400µm to 600µm porosity. The Steerable Plateau Ti system is complemented by Life Spine’s Centric-T Pedicle-Based Retractor system and the Avatar MIS Spinal Fixation system.
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